CLASS II Drug recall · Reported 12 Jan 2022 · FDA Enforcement Report
Pregabalin Capsules, 50 mg recalled by Sun Pharmaceutical Industries
SUN Pharmaceutical Industries is recalling Pregabalin Capsules, 50 mg, distributed nationwide in the US. The recall was initiated on 22 Oct 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0361-2022
- FDA event ID
- 88927
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Pregabalin
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2021
- FDA classified
- 6 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 22 Oct 2021 | Recall initiated by company | |
| 6 Jan 2022 | Classified by FDA | +76 days |
| 12 Jan 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15 Dadra-396 191, (U.T. of D & NH), India, NDC 47335-687-88.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Which lots are affected?
Lot number: DNC0432A, expiration 01/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Pregabalin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pregabalin Capsules 50mg recalled by Rising Pharma HoldingPregabalin | Rising Pharma Holding | Packaging Defects | Nationwide |
| Drug | CLASS II | Pregabalin Capsules 300mg recalled by Cardinal HealthPregabalin | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Lyrica (pregabalin) capsules, 50 mg recalled by PfizerLyrica | Pfizer | Other | Nationwide |
| Drug | CLASS II | Lyrica (pregabalin) capsules, 75 mg recalled by PfizerLyrica | Pfizer | Other | Nationwide |
| Drug | CLASS II | Pregabalin, Capsule, 25 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |