Heritage Pharmaceuticals Inc — FDA Facility Profile
Heritage Pharmaceuticals Inc is an FDA-inspected facility (FEI 3013995812) located in East Brunswick, NJ, US. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- Dec 14, 2017: No Action Indicated (NAI)
- Inspections on record
- 3 (1 OAI, 2 NAI)
- Last OAI inspection
- May 27, 2015
- Warning letters
- 1 listed by FDA for this FEI, latest Nov 5, 2015
- Recalls as the recalling firm
- 6, latest Jul 30, 2026
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Dec 14, 2017 | No Action Indicated (NAI) | No citations listed |
| Oct 3, 2016 | No Action Indicated (NAI) | No citations listed |
| May 27, 2015 | Official Action Indicated (OAI) | Late submission of 15-day report (21 CFR 314.80(c)(1)(i)) Failure to report non-alert ADEs (21 CFR 314.80(c)(2)) Interval (21 CFR 314.80(c)(2)) Late submission of quarterly safety reports (21 CFR 314.80(c)(2)) and 3 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 30, 2026 | Not yet classified | D-0768-2026 | CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL… Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. |
| Oct 6, 2025 | Not yet classified | D-0107-2026 | Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx… and 5 more products CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. |
| Nov 23, 2022 | Not yet classified | D-0072-2023 | Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet… Subpotent Drug |
| Apr 21, 2021 | Not yet classified | D-0367-2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals… Labeling: Incorrect or Missing Lot and/or Exp Date |
| Oct 23, 2020 | Not yet classified | D-0108-2021 | Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by… Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability… |
| May 3, 2019 | Not yet classified | D-1287-2019 | Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only
Manufactured by… and 4 more products CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim… |
Facility details
- Company
- Heritage Pharmaceuticals Inc
- Location
- East Brunswick, NJ (US)
- Source
- inspections